Infection/Inflammation

Daily Cranberry Juice for the Prevention of Asymptomatic

Bacteriuria in Pregnancy: A Randomized, Controlled Pilot Study
Deborah A. Wing,*, Pamela J. Rumney, Christine W. Preslicka and Judith H. Chung
From the Department of Obstetrics and Gynecology, University of California, Irvine, Orange (DAW, PJR, JHC), and Long Beach
Memorial Medical Center and Millers Childrens Hospital, Long Beach (CWP), California

Purpose: We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic
bacteriuria and symptomatic urinary tract infections.
Materials and Methods: A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A cranberry 3 times daily (58), B cranberry at breakfast then placebo at lunch and dinner (67), and Cplacebo 3 times daily (63).
After 27.7% (52 of 188) of the subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to
improve compliance.
Results: There were 27 urinary tract infections in 18 subjects in this cohort, with 6 in 4 group A subjects, 10 in 7 group B
subjects and 11 in 7 group C subjects (p 0.71). There was a 57% and 41% reduction in the frequency of asymptomatic
bacteriuria and all urinary tract infections, respectively, in the multiple daily dosing group. However, this study was not
sufficiently powered at the alpha 0.05 level (CI 0.14 1.39 and 0.221.60, respectively, incidence rate ratios). Of 188 subjects
73 (38.8%) withdrew, most for gastrointestinal upset.
Conclusions: These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria
and symptomatic urinary tract infections in pregnancy. Further studies are planned to evaluate this effect.
Key Words: urinary tract infections, bacteriuria, vaccinium macrocarpon, pregnancy

symptomatic bacteriuria in pregnancy has an estimated prevalence of 5% to 12%,1 4 and is associated

with a variety of adverse perinatal outcomes including preterm delivery and low birth weight.5 8 A primary
goal in the detection and treatment of ASB during pregnancy is the reduction of risk of acute pyelonephritis. Preterm births may be associated with acute pyelonephritis.1,4
There has been little progress in this area in the last several
decades. The development of alternative methods for preventing asymptomatic bacteriuria and subsequent pyelonephritis would represent a major advancement in prenatal
care.
Cranberry juice and encapsulated powders are commonly used to prevent or treat urinary tract infections.
Scientific evidence to support the use of cranberry for the
prevention/treatment of UTIs is limited by a lack of focus
on reproductive age women, identification of symptomatic
UTIs following daily cranberry juice ingestion, and inadequate assessment of dosing regimens and duration of
therapy. Most importantly to our knowledge there are no

Submitted for publication December 28, 2007.

Study received institutional review board approval.
Supported by the National Institute of Diabetes and Digestive and
Kidney Diseases R21DK65827-01 and NCCAM NOT-CA-02-014.
Clinical Trials Registration NCT00093938.
* Correspondence: Department of Obstetrics-Gynecology, University of California, Irvine, 101 The City Drive South, Suite 800, Bldg.
56, Orange, California 92868 (telephone: 714-456-5967; FAX: 714456-7754; e-mail: mfm@uci.edu).
Financial interest and/or other relationship with National Institute of Diabetes and Digestive and Kidney Diseases.

For another article on a related topic see page 1522.

0022-5347/08/1804-1367/0
THE JOURNAL OF UROLOGY
Copyright 2008 by AMERICAN UROLOGICAL ASSOCIATION

data regarding the efficacy of daily cranberry ingestion

during pregnancy for the prevention of ASB.9,10
Using a hypothesis that a strategy to prevent the development of ASB in pregnancy could lead to improved pregnancy outcomes by reducing preterm births, we performed
this investigation to provide preliminary data on the effect of
daily cranberry juice cocktail ingestion on the frequency of
ASB and other UTIs in pregnancy. Outcomes studied included the incidence of ASB, tolerability and side effect
profile of daily cranberry juice ingestion, and patient adherence to dosing regimens.
MATERIALS AND METHODS
Study Population
Eligible pregnant subjects at less than 16 weeks of gestation
presented initially for prenatal care at UCI Medical Center
or LBMMC. Institutional review board approval was obtained at both institutions. Subjects were excluded from
analysis for previous underlying medical conditions including diabetes mellitus, renal failure, sickle cell disease,
chronic hypertension, chronic renal disease, previous or current antimicrobial therapy at the time of screening or within
2 weeks of screening and known urological abnormalities.
Each subject also had a pretreatment urine culture performed to ensure the absence of ASB. Written informed
consent was obtained.
Study Methods
Women were followed through delivery and the immediate
puerperium. Each subject was contacted weekly for 6 weeks

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Vol. 180, 1367-1372, October 2008

Printed in U.S.A.
DOI:10.1016/j.juro.2008.06.016

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CRANBERRY JUICE FOR ASYMPTOMATIC BACTERIURIA IN PREGNANCY

via telephone by a research coordinator inquiring about

compliance, tolerance and side effects of the daily juice regimen. For those subjects who reported poor compliance or
tolerance we offered more frequent research coordinator contact or clinic followup. Followup clinic visits were concurrent
with monthly prenatal care visits. In addition, subjects
maintained dietary diaries in which they placed labels from
the bottles of juice they consumed and recorded side effects.
At the followup visits a clean catch urine specimen was
collected for dipstick urinalysis. If positive for leukocyte
esterase and nitrites, reflex microscopy and culture and
susceptibility were performed. Subjects were queried for
symptoms of urinary tract infection or preterm labor.
All subjects were instructed to ingest 240 ml bottled
cranberry juice or placebo at each meal (3 times daily) until
delivery. We instructed subjects not to consume cranberry
products other than those for the study. We also educated
them about UTIs and hygiene practices to aid in the prevention of UTIs including adequate fluid intake, frequent voids
and voiding after coitus. They were also educated about the
importance of compliance with recommended therapies.
Randomization
Using a computer generated randomization table women
were randomized to receive active CJC with each meal, or
CJC at breakfast followed by placebo at lunch and dinner, or
placebo at each meal. Randomization was stratified by site.
After 52 subjects were enrolled in study the dosing frequency was reduced to twice daily because of a high withdrawal rate and poor tolerability of the 3 times daily dosing
regimen. The main side effects were gastrointestinal. Thus,
the protocol was modified to CJC twice daily (breakfast and
dinner), or CJC at breakfast and placebo at dinner, or placebo twice daily. In addition, we permitted a modification of
the cranberry dosing schedules to allow for step-down dosing
to once daily for those with moderate to severe gastrointestinal disturbance. The identities of the treatment assignments were not known to the subjects, research coordinators
or investigators and unblinding did not occur until termination of the investigation.
Study Product
A low calorie CJC beverage containing 27% cranberry juice
was supplied by Fisher BioServices Corp. in collaboration
with Ocean Spray Cranberries, Inc. It was formulated to
meet research needs under contract with the NCCAM (NOTCA-02-014) following competitive award. Although not specifically commercially available, it is similar in composition
to Ocean Spray low calorie CJC found in retail stores. The
CJC was sweetened with sucralose (Splenda). A Drug Master File for this research grade low calorie CJC is on file with
the United States Food and Drug Administration. Berries
from Vaccinium macrocarpon Aiton were used. Each dose
consisted of 240 ml CJC with a mean proanthocyanidin
concentration of 80 mg per bottle by the DMAC (N,N-dimethylacetamicle) method. The CJC was stored under refrigerated conditions.
The placebo beverage was formulated by Ocean Spray
Cranberries, Inc. to mimic the flavor (including sugar and
acid profile) and color of the cranberry beverage. There were
no cranberry ingredients in the placebo beverage. It was
bottled in the identical polypropylene bottles used for the

active beverage and was also stored under refrigerated conditions.

Outcome Measures
The primary outcome measure was the number of cases of
bacteriuria, defined as having a urine culture with 100,000
or more of a single uropathogen (measured as cfu per ml).
ASB was defined as urine cultures consistent with bacteriuria without symptoms. Acute cystitis was diagnosed in
subjects with symptoms of dysuria, urinary frequency
and/or urinary urgency, and urine cultures consistent with
bacteriuria. Acute pyelonephritis was diagnosed in subjects
with flank pain, fever (temperature greater than 100.4F),
chills, nausea and/or vomiting, with urinalyses and/or urine
cultures indicative of bacteriuria. We defined treatment failure as any case of bacteriuria, acute cystitis or acute pyelonephritis. Those women with treatment failure continued
drinking the investigational juice through delivery.
We used standardized treatments for ASB, acute cystitis
and acute pyelonephritis. Generally for ASB and acute cystitis 500 mg cephalexin 4 times daily for 7 days was prescribed, and for acute pyelonephritis 1 or 2 gm intravenous
cefazolin 4 times daily was given until the subject was 2 days
without fever. Parenteral gentamicin could be added based
on clinical response. Subjects with acute pyelonephritis were
subsequently treated with 500 mg oral cephalexin 4 times
daily to complete a minimum of 10 days of antibiotic therapy. Any subject with ASB or a symptomatic urinary tract
infection continued with juice therapy during treatment.
Cultures were repeated within 2 weeks of treatment completion to assess eradication of bacteria. We anticipated 20%
to 30% of women would require a second course of a different
antibiotic based on susceptibility testing. At each monthly
visit compliance was assessed using dietary diaries (as previously described) and a self-reported assessment of percent
compliance with the dosing schedule.
Sample Size and Data Analysis
An efficacy trial was not feasible with the available resources and the data were lacking with which to support a
larger trial. Thus, we performed a pilot trial to generate
preliminary data for the design of a large scale clinical trial.
Additional outcome measures included effective resolution
of ASB with antibiotic treatment, side effects, recurrence
rates of ASB and preterm delivery with its associated neonatal morbidities. Toxicities, side effects, tolerability and
compliance were reviewed by a preappointed data safety
monitoring committee at 4 times during the study period (at
6, 12 and 18 months, and at study termination).
We used SAS STATA SE version 10.0 for data management and analysis. ANOVA was used for continuous variables. The chi-square or Fishers exact tests were used for
categorical variables. Poisson regression was performed to
obtain IRRs for the number of urinary tract infections. We
also compared the time to first diagnosis of ASB using
Kaplan-Meier plots and log rank tests. The data analyses
were performed on an intent to treat basis.
RESULTS
From July 2005 through July 2007 a total of 188 women
were enrolled in this pilot investigation (see figure). There

CRANBERRY JUICE FOR ASYMPTOMATIC BACTERIURIA IN PREGNANCY

1369

Participant flow chart for cranberry for prevention of asymptomatic bacteriuria in pregnancy

were no differences in demographic characteristics (table 1).

There were 27 UTIs in this cohort. There was 1 case of
Enterobacter faecalis cystitis in a woman in group B and 3
cases of pyelonephritis due to Escherichia coli (2 in group A,
1 in group B), with the remainder of cases attributed to ASB
(table 2). Five women had more than 1 UTI. There was a
trend toward fewer UTIs, asymptomatic and symptomatic,
in those women who received multiple daily doses of CJC
compared to those who received placebo. This trend persisted with single daily dosing of CJC although the magnitude of the difference was less (table 3).
More women in the once daily dosing group and the
placebo group were likely to have at least 1 UTI during
the study compared to the multiple daily dosing group (7
of 67 [10.4%] and 7 of 63 [11.1%] vs 4 of 58 [6.9%],
respectively, Fishers exact test p 0.71). Similar results
were seen in evaluating only those UTIs due to enteric
bacteria (5 of 67 [7.5%], 5 of 63 [7.9%] and 3 of 58 [5.2%],
respectively, p 0.83), and the trend toward reduction in
ASB alone persisted for multiple daily cranberry juice cocktail dosing (IRR 0.43, 95% CI 0.14 1.39) as well as for single
daily cranberry juice cocktail dosing (IRR 0.85, 95% CI 0.34
2.08).
Compliance and tolerability were considerable obstacles
during this investigation. Despite the change from 3 times
daily to twice daily dosing actual dosing regimens did not

differ among groups with 50.7% (34 of 67) of group A, 39.7%

(23 of 58) of group B and 55.5% (35 of 63) of group C
consuming placebo juice once or twice daily, p 0.45. Compliance rates differed among groups with total doses prescribed for the duration of participation consumed at 65.7%
30.9% in group A, 78.7% 29.2% in group B and 76.9%
24.9% in group C, p 0.03. Of 188 subjects 73 (38.8%) could
not complete the study and withdrew, most for gastrointestinal
upset including nausea, vomiting, diarrhea and dislike of
taste (44 of 73). There were fewer withdrawals after the
dose change was made (50 of 136, 36.8%) vs before (23 of
52, 44.2%, p 0.35).
Evaluating the cohort on an intent to treat basis the
median number of days in study was 152.5 (IQR 56 to 183)
for group A, 158 (IQR 61 to 181) for group B and 171 (IQR
76 to 185) for group C, p 0.26. For those who completed
the study protocol the median number of days in study
was 183 (IQR 161 to 195) for group A (41), 177 (IQR 165 to
185) for group B (31) and 182 (IQR 169 to 192) for group
C (43), p 0.29. For those who withdrew from study the
median number of days in study was 56 (IQR 21 to 77) for
group A (27), 56 (IQR 30 to 90) for group B (26) and 55.5
(IQR 28.5 to 80) for group C (20), p 0.85. There were no
differences between the groups with regard to obstetric or
neonatal outcomes (table 4). No preterm deliveries at less

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CRANBERRY JUICE FOR ASYMPTOMATIC BACTERIURIA IN PREGNANCY

TABLE 1. Demographics by group

No. women
Mean maternal age SD
No. gravida (%):
1
2
3 or More
No. para (%):
0
1
2 or More
No. ethnicity (%):
NonHispanic white
Hispanic white
NonHispanic black
Asian/other
No. enrollment site (%):
LBMMC
Santa Ana (UCI)
Manchester (UCI)
No. insurance status (%):
Government
Private/other
No. yrs school (%):
08
912
13 or More
No. employment status (%):
Employed
Not employed
No. history of prior UTI (%):
Yes
No

Group A

Group B

Group C

p Value*

58
25.8 5.6

67
27.7 5.4

63
25.6 5.0

0.058

16 (27.6)
14 (24.1)
28 (48.3)

12 (17.9)
21 (31.3)
34 (50.8)

27 (42.9)
15 (23.8)
21 (33.3)

0.034

22 (37.9)
17 (29.3)
19 (32.8)

18 (26.9)
23 (34.3)
26 (38.8)

30 (47.6)
22 (34.9)
11 (17.5)

0.053

11 (18.9)
40 (68.9)
3 (5.2)
4 (6.9)

11 (16.4)
45 (67.2)
6 (8.9)
5 (7.5)

10 (15.9)
47 (74.6)
4 (6.4)
2 (3.2)

0.89

23 (39.7)
25 (43.1)
10 (17.2)

28 (41.8)
24 (35.8)
15 (22.4)

26 (41.3)
27 (42.9)
10 (15.9)

0.84

44 (75.9)
14 (24.1)

53 (79.1)
14 (20.9)

50 (79.4)
13 (20.6)

0.88

8 (13.8)
33 (56.9)
17 (23.3)

8 (11.9)
41 (61.2)
18 (26.9)

4 (6.3)
40 (63.5)
19 (13.2)

0.72

25 (41.4)
34 (58.6)

27 (40.3)
40 (59.7)

26 (41.3)
37 (58.7)

0.99

17 (29.3)
41 (70.7)

18 (26.9)
49 (73.1)

20 (31.8)
43 (68.2)

0.83

* ANOVA for continuous variables, Fishers exact or chi-square test for categorical variables.
There were no Hispanic black subjects in the study population.

than 34 weeks occurred in women with UTIs during this

investigation.
DISCUSSION
Our investigation provides support for a unique approach to
the reduction of asymptomatic bacteriuria in pregnancy and
its associated adverse perinatal outcomes. The standard of
obstetric care remains screening for asymptomatic bacteriuria and treatment if the diagnosis is made.11 However, the

TABLE 2. Types of urinary tract infections with uropathogens

Total
UTIs
Asymptomatic bacteriuria:
E. coli
Citrobacter freundii
Group B streptococcus
Proteus mirabilis
Other
Total
Symptomatic bacteriuria
(cystitis):
Enterobacter cloacae
Total
Pyelonephritis:
E. coli
Total
Total subjects with UTIs (%)

9
5
3
3
3
23

No.
Group A
1*

1
1

No.
Group C
3
1
1
2

1
1
3
3

No.
Group B

current recommendations for screening may not apply to

those women with poor compliance or late entry to prenatal
care and do not address issues related to provider error or
optimal posttreatment surveillance. The option to combine
routine urinary screening with a nonharmful foodstuff,
cranberry, to reduce the risk of gestational bacteriuria and
its attendant potential complications is attractive for public
health and cost considerations, especially when factoring in
the expense of caring for a premature newborn and the
subsequent costs related to the lifelong disability that often
affects survivors of premature birth.
The mechanism by which cranberry may prevent urinary
tract infection is unknown although there is a growing body of
evidence that proanthocyanidins or condensed tannins, components in many berry products, inhibit the adhesion of piliated
enteric bacteria such as E. coli to the uroepithelium.12,13
In the 2001 Cochrane Library review of cranberry for the
prevention and treatment of UTI the authors believed that
there was preliminary evidence supporting its efficacy but that
the published trials had major limitations including lack of
control groups, small sample sizes, lack of controlled diets or

1
2*

4 (6.9)

TABLE 3. Incidence rate ratios for cases of asymptomatic

bacteriuria and UTIs (intent to treat)
(10.4)

IRR (95% CI)*

7 (11.1)

* E. coli pyelonephritis also developed in 1 subject with E. coli ASB.

One subject with 2 bouts of E. coli ASB.
E. coli pyelonephritis also developed in 1 subject with 2 bouts of E. coli
ASB.
One subject with 5 bouts of C. freundii ASB.
One subject with 2 bouts of P. mirabilis ASB.

Group A
Group B
Group C
* Poisson.

Asymptomatic Bacteriuria

All UTIs

0.43 (0.141.39)
0.85 (0.342.08)
1.0

0.59 (0.221.60)
0.85 (0.362.01)
1.0

CRANBERRY JUICE FOR ASYMPTOMATIC BACTERIURIA IN PREGNANCY

1371

TABLE 4. Obstetric and neonatal outcomes

Group A
Mean gestational age (wks) at delivery SD (No.)
No. preterm delivery less than 37 wks (%):
Yes
No
No. preterm delivery less than 34 wks (%):
Yes
No
No. route of delivery (%):
Spontaneous vaginal delivery
Instrumented vaginal delivery
Cesarean/cesarean hysterectomy
Mean birth wt SD (gm)
No. low birth wt (%):
Yes
No
No. 1-min Apgar less than 7 (%):
Yes
No
No. 5-min Apgar less than 9 (%):
Yes
No
No. admission to neonatal intensive care unit (%):
Yes
No

38.7 3.0

Group B
38.2 3.6

(55)

Group C
(58)

38.8 2.5

p Value*
(57)

0.027

6
49

(10.9)
(89.1)

11
47

(19.0)
(81.0)

4
53

(7.0)
(93.0)

0.15

2
53

(3.6)
(96.4)

4
54

(6.9)
(93.1)

2
55

(3.5)
(96.5)

0.73

40
(70.2)
2
(3.5)
15
(26.3)
3,423 644

0.80
0.31

36
(66.7)
5
(9.3)
13
(24.0)
3,270 522

41
(70.7)
4
(6.9)
13
(22.4)
3,296 591

4
54

(6.9)
(93.1)

4
63

(6.0)
(94.0)

2
61

(3.2)
(96.3)

0.72

3
50

(5.5)
(94.5)

5
52

(8.8)
(91.2)

2
55

(3.5)
(96.5)

0.52

4
49

(7.5)
(92.5)

5
52

(8.8)
(91.2)

5
52

(8.8)
(91.2)

1.0

3
50

(5.7)
(94.3)

7
52

(11.9)
(88.1)

6
48

(10.5)
(89.5)

0.51

* ANOVA for continuous variables, Fishers exact or chi-square test for categorical variables.

dietary assessment, inappropriate analysis of data for dropouts

or withdrawals, and lack of blinding.9 Importantly this Cochrane review noted that there were no investigations of the
role of cranberry in preventing UTI in young patients or in
pregnant women. This review included only 5 trials, all of
which lacked a description of the product. Outcome measures
were also varied with some researchers focusing on bacteriuria
and pyuria, and others on symptomatic UTIs. The appropriate
product, dose, duration of intervention and mechanism(s) of
action were largely unknown or were not clearly elucidated.
The same authors of the Cochrane review published updates in
200710,14 and concluded that on meta-analysis of 4 high quality
randomized controlled trials1518 cranberry products significantly reduced the incidence of symptomatic UTIs in 12
months (RR 0.66, 95% CI 0.47 0.92) compared with placebo or
control, particularly in women with recurrent UTIs. These
studies involve primarily women,15,16 subjects with spinal cord
injury17 or the elderly.18 To date to our knowledge no investigations on the effect of cranberry on urinary tract infection in
pregnant women have been published.
Similar to our clinical trial withdrawals or losses to
followup are significant in other published studies, as
high as 47% or more.10,18,19 This has led some to suggest
that drinking considerable amounts of cranberry juice
during a long period such as the duration of pregnancy
may not be acceptable.10 However, the possibility exists
that different cranberry formulations such as capsules or
tablets will have better efficacy and improved compliance.
Stothers reported yearlong compliance rates of 70% to
100% with cranberry capsules, and lesser rates with cranberry juice in a trial evaluating the clinical and costeffectiveness of cranberry for uroprotection.15 The nausea
and vomiting during pregnancy certainly were poor prognosticators for compliance during this investigation, and
any gastrointestinal symptoms related to intolerability of
the juice or placebo may have exacerbated or been exacerbated by physiological changes in pregnancy. We altered the treatment regimens after approximately a third
of the subjects were randomized due to concerns about

compliance. There was a mild improvement in retention of

compliant subjects in the investigation after this alteration was made. As there are in vitro data to suggest that
the anti-adhesion activity of cranberry juice on fimbriated
E. coli persists for 10 hours after ingestion, twice daily
dosing of cranberry juice may be adequate for the prevention of UTIs in pregnancy.20
We acknowledge the limitations of this investigation including the small sample size and the lack of bioassay for
compliance. As expected compliance and tolerability to the
cranberry juice product were limitations, and resulted in a
more than 30% dropout rate. As a result of these difficulties
a change in the dosing regimens was required during the
study. A minor weakness is that the provision of additional
followup for those subjects with poor tolerance or compliance
to the juice could have introduced bias in the ultimate clinical outcomes. Conclusive information about the benefits of
daily cranberry juice ingestion can only be gleaned from
larger clinical trials in which consistent treatments are applied. Additional evidence will soon be available from other
NCCAM supported clinical trials in which the same cranberry juice and placebo products were used.

Abbreviations and Acronyms

ASB
CJC
IRR
LBMMC
NCCAM

asymptomatic bacteriuria
cranberry juice cocktail
incidence rate ratio
Long Beach Memorial Medical Center
National Center for Complementary and
Alternative Medicine
UCI University of California, Irvine
UTI urinary tract infection

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